CMC Project Manager
Heat Biologics is a clinical-stage biopharmaceutical company and Pelican Therapeutics is a wholly-owned subsidiary of Heat. Together they are progressing a portfolio of immunotherapy products to fight cancer. In the next year, Heat/Pelican will have multiple products in numerous early phase clinical programs. The CMC Project Manager will work with the CMC group and manage activities at multiple CMOs and analytical contract laboratories to ensure product development project goals and milestones are achieved. This position will be based in Durham, North Carolina and the successful candidate must be organized, self-motivated, and able to thrive in a fast-paced dynamic biotech environment where flexibility, tolerability to rapid change, and drive to make a significant impact is essential.
- Interact and communicate with contract manufacturing and analytical laboratory organizations to coordinate process development, assay development and preclinical development programs and activities for CMC development programs.
- Maintain detailed status updates to support multiple CMC product development projects.
- Communicate project status updates and actions required to internal team members clearly and accurately.
- Identify issues affecting project timelines and ensure management awareness to facilitate decision-making to mitigate such issues.
- Maintain and ensure availability of CMC documentation necessary for regulatory filings or health authority interactions.
- Monitor project costs to maintain budget for the CMC group.
- Assist Clinical Operations group as necessary to ensure continuity of material availability for use in supporting ongoing clinical trials.
- Perform other duties as assigned.
- BA/BS degree; PMP certification preferred.
- 5+ years of experience in the pharmaceutical/biotech clinical research industry; with at least 3 years of relevant CMC Project Management work experience.
- Ability to prioritize, organize and manage multiple projects simultaneously.
- Working knowledge of GMP and GLP manufacturing and laboratory environments/requirements and familiarity with clinical trial packaging/labeling and distribution.
- Strong cross-functional interpersonal skills.
- Excellent oral and written communication and attention to detail.
- Proficiency in MS Office suite, including Word, Excel, and PowerPoint.
- Ability to travel up to 10% as needed.
Please fill out the form below to submit your application.